This is an open label-pilot study to assess the efficacy and safety of a novel cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. Often times, these children have difficulty in finding easily applied treatments to make their psoriasiform and ichthyotic plaques more manageable. We propose the use of a cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it will lead to regression of involved areas and decreased erythema and warty-like appearance of the plaques. We plan to enroll children with syndromic ichthyoses over the age of 1 year for a 12 month study with a total of 5 visits and 5 phone calls.

Topical lovastatin applied to red, rashy areas two times daily for 12 months

Eligibility

Ages Eligible for Study:

1 Year and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Informed Consent form signed by the subject or subject's legal representative; also, if the subject is under the age of majority but capable of providing assent, signed assent from the subject.

Diagnosis of a syndromic ichthyoses (verified by Dr Amy S. Paller).

Children and adults 12 months of age and above

Exclusion Criteria:

Use of any investigational drug within the 30 days before enrollment.

Current malignancy.

Pregnancy or breastfeeding during the study. (All female subjects of childbearing potential will be assessed for pregnancy at all visits.)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110642

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Amy S Paller, MD

Northwestern University

More Information

No publications provided

Responsible Party:

Amy Paller, Professor and Chair of Department of Dermatology, Professor of Pediatrics, Northwestern University